Evaluating the Impact of Enhanced Health Facility-based Care for Malaria and Febrile Illnesses in Children in Tororo, Uganda
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25,000
- 试验地点
- 1
- 主要终点
- Prevalence of anemia in children under five in the cross-sectional surveys
研究概览
简要总结
The investigators propose to assess whether an intervention to build capacity and improve delivery of drugs and diagnostics at government-run health facilities improves the health of children and quality of care delivered, as compared to 'standard care' currently available at health facilities, supplemented by services provided through the private sector and community-based interventions. The target population will be divided into 20 clusters, defined as the catchment area of lower-level public health facilities. Clusters will be randomized to the health facility intervention (HFI) or to standard care delivered from government-run health facilities, supplemented by services provided through the private sector and community-based interventions. The intervention is designed to address barriers to delivering quality care at health centers and will focus on three components: (1) training in-charges in health center management, (2) providing training to health workers in fever case management and patient-centered services, and (3) ensuring adequate supplies of artemether-lumefantrine and RDTs. Outcomes will be measured in three distinct populations: (1) cross-sectional surveys of children under 15 years randomly selected from households within the clusters; (2) a cohort of children under five randomly selected from households within the clusters and followed for 2 years; and (3) patients attending all government-run health facilities, including children under five and their caregivers participating in exit interviews on selected days every six months. The primary outcome of the study is prevalence of anemia in children under five.
详细描述
Study overview:
We are proposing to evaluate enhanced health facility-based care for malaria and febrile illnesses in children in Tororo district using a cluster randomized design. The health facility intervention (HFI) will aim to address barriers to achieving good quality health care that were identified in our formative research. The focus of our intervention will be providing RDTs and training health workers in management of both malaria and non-malarial febrile illnesses.
Study site:
The study will be conducted in Tororo district, an area with very high malaria transmission intensity. The estimated entomologic inoculation rate (EIR) in Tororo is 562 infective bites per person-year, and the prevalence of parasitemia among children aged 5-9 years is 63.5%. The five sub-counties of West Budama North Health Sub-district (Nagongera, Paya, Kirewa, Kisoko, and Petta), and two sub-counties of West Budama South Health Sub-district (Mulanda and Rubongi) will be included in the study population.
Study population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •FOR THE COHORT STUDY
- •Inclusion Criteria:
- •age < 5 years
- •agreement of parents or guardians to provide informed consent
排除标准
- •intention to move during the follow-up period
- •FOR THE CROSS-SECTIONAL SURVEY:
- •Inclusion Criteria:
- •age < 15 years
- •agreement of parents or guardians to provide informed consent
- •agreement of a child aged 8 years or older to provide assent.
- •Exclusion Criterion:
- •inability to locate the child.
结局指标
主要结局
Prevalence of anemia in children under five in the cross-sectional surveys
时间窗: annually
Proportion of hemoglobin measurements \< 11.0 g/dL as measured in cross sectional surveys. Anemia will be classified according to severity: mild (Hb 8.0 - 10.9), moderate (Hb 5.0 - 7.9), severe (Hb \< 5.0).
次要结局
- Prevalence of parasitemia in children under five in the cross-sectional surveys(annually)
- Stock-outs of ACTs in the Health facility surveillance(Every two months)
- Knowledge questionnaire scores for Health workers(Annually)
- Inappropriate treatment of malaria in children under five in the Patient Exit Interviews(Every six months)
- Patient satisfaction with health care in caregivers of children under five in the Patient Exit Interviews(Every six months)
- Patient attendance in the Health facility surveillance(Every two months)
- All-cause mortality(Annually)
- Incidence of hospitalizations in children under five in the cohort study(two years)
- Incidence of illness episodes in children under five in the cohort study(Two years)
- Incidence of febrile episodes in children under five in the cohort study(Two years)
- Prompt effective treatment of fever in children under five in the cohort study(Two years)
- Appropriate treatment of malaria in children under five in the Patient Exit Interviews(Every six months)
- Incidence of serious adverse events in children under five in the cohort study(Two years)
- Prompt effective treatment of malaria in children under five in the cohort study(Two years)
- Prevalence of anemia in children aged 5-15years in the cross-sectional surveys(annually)
研究者
Sarah Staedke
Principal Investigator
Uganda Malaria Surveillance Project